General Terms and Conditions of Delivery and Payment

1. General and Valid Areas

1.1 Customers are entities having legal capacity who we enter into a business relationship with and who act in fulfillment of his/her commercial or free-lance activities. 1.2 We supply medical products (here also referred to as “Goods”) to the customers. Delivery is based on the following and the respective conditions included with the goods that are realized by order placement or acceptance of delivery. 1.3 The following conditions are valid for all of our offers, sales and deliveries to customers insofar as nothing else has been agreed upon in writing. Significant is the issue valid at the time of conclusion of contract. 1.4 The following conditions supersede all previous versions of our General Terms and Conditions of Sale as agreed upon with the customer. 1.5 We do not accept any terms and conditions of the customer contrary to, deviating from or as a supplement to our own, even if known, unless we have expressly agreed to such in writing

2. Conclusion of Contract

2.1 The conditions for our products are non-binding. Our Internet product range does not represent an offer but rather a non-binding invitation to the customer to place an order. We reserve the right to make acceptable changes of a technical nature as well as other changes in form, color or weight. 2.2 Customer orders are a binding declaration of the contract offer. Acceptance of a telephone order does not constitute a binding acceptance on our part. 2.3 We are authorized, within a two week period, to either accept an order arising from a contract offer or to decline acceptance of an order without reason. 2.4 Customer orders shall only be deemed as accepted when confirmed by us in writing (“Order Confirmation”). The scope of delivery is defined by our written order confirmation. In the event of custom-made products, an order occurs only with written confirmation from the customer. 2.5 We reserve the right to partial or non-performance of a contract in case of incorrect or improper deliveries by our suppliers. This shall apply only when we are not responsible for such failure to deliver. In the event of non-availability or only partial availability of the goods, we will immediately inform the customer. A return will immediately be refunded. 2.6 In the event that the customer orders goods electronically, we will save the contract text which is then sent together with the legally effective corresponding Terms and Conditions of Sale per E-Mail after the contract has been concluded.

3. Delivery and Delay in Delivery

3.1 Our delivery dates are only binding when they are confirmed in writing. The delivery date begins with sending of our order confirmation. 3.2 The delivery time is met when the item to be delivered has left our premises by the end of the stipulated time or is notified as ready for dispatch. 3.3 Force majeure, operational breakdowns or other circumstances which are beyond our or our suppliers control shall suspend our obligation for delivery and its‟ consequences for the duration of the interference. 3.4 Should delivery be delayed, the customer can expect the following: a) We are liable according to statutory provisions; to the extent that the delay in delivery is due to an intentional or grossly negligent breach of contract on our part; our liability for damages is limited to the foreseeable and typical damage. Insofar as the delay in delivery is not based upon a willful contractual infringement for which we are responsible, our liability to pay compensation shall be limited to foreseeable damages which typically occur. b) According to the requirements of law we are liable to the extent that we culpably violate an important contractual obligation, in this case however, liability for damages is limited to the foreseeable and usually occurring damages. Contract obligations are regarded to be of fundamental importance if compliance with these obligations is essential for the execution of the contract and if the customer legitimately trusts in the compliance with this obligation. c) Insofar as the delay in delivery is based upon a culpable infringement of a non-important contractual obligation, the customer is entitled to claim only an inclusive sum in compensation for the delay of 3% of the overdue value of the order for each complete week up to a maximum of 10% of this order value for proven losses due to the delay. Furthermore, in such cases no replacements will be made.

4. Partial Shipments, Delivery on Request

4.1 We are authorized to fulfill an order, also with partial shipments. 4.2 Delivery agreements without fixed delivery times (“on request”) may be agreed upon. We reserve the right to only accept the delivery agreement when it defines a specific “delivery on request” timeframe. Should the delivery quantity not be called up within the “on request” timeframe, we are authorized to demand the (remaining) selling price concurrently against delivery of the remaining quantity.

5. Reservation of Title

5.1 We reserve the title of the goods we have delivered until the customer has settled all claims arising out of our business relation. When the value of the goods subject to retention exceeds 20% of the claims resulting from the current business relations then we are obligated to release the goods subject to retention at the customer’s requests. 5.2 The customer is obligated to handle the goods with care during the retention of title. The customer is required to inform us immediately, in writing, of any access to the goods by Third Parties in particular of any levies of execution and possible damage or destruction of the goods. The customer must notify us immediately of any change in ownership of the goods or any change of his address. The customer is liable to pay compensation to us for any damage or costs caused by a breach of the above obligations or by not adequately intervening against access to the goods by Third Parties. 5.3 We are entitled, should the customer be in violation of the contract, especially in case of default in payment, to repudiate the contract and request surrender of the goods. This is also valid by violation of duty according to Numbers 5.2 of this regulation when we can no longer be expected to reasonably adhere to this agreement. 5.4 The customer is entitled to resell the goods within the context of ordinary business transactions. They shall settle all outstanding debts that they incur through the resale of the goods to a Third Party to the value of the invoice amount immediately. We hereby accept the assignment. The customer is entitled on a revocable basis to collect the debts due even after the assignment. We reserve the right to collect the demands ourselves if the customer does not meet their payment obligations properly and is in default of payment. 5.5 The customer is obligated to secure the goods subject to retention in the event of the resale, and especially our retention of title must be passed on to his customer. If it appears to us that the realization of our claims might be endangered, the customer shall, General Terms and Conditions of Payment and Delivery Page 2 of 3 Status: 01.11.2010 at our request, enable us to take back the retained goods, notify its customers of the claim assignment and provide us with all the necessary information and documentation. The retraction of reserved proprietary rights does not amount to annulment of the contract. 5.6 The processing of the goods by the customer must always occur in the name of and on behalf of us. Where such processing is performed, we shall be entitled to co-ownership in the new objects in proportion to the value of the goods we deliver. The same shall apply if the goods are mixed or processed with other objects which do not belong to us.

6. Shipment and Transfer of Risk

6.1 The risk of accidental loss or depreciation of the goods shall be passed on to the customer upon delivery. When we deliver the goods, the risk of damage of goods shall be transferred to the transportation agent. This also applies in case of partial deliveries or in case we have accepted other services, e.g. shipment or transportation itself. 6.2 The transfer is also deemed complete even if the customer is in default of acceptance of the goods 6.3 In case of delay of shipment due to reasons within the customer’s responsibility, the risk of damage of the goods shall pass on to the customer on the day of “ready for dispatch”. In this case, we will store the goods at the customer’s expense and will charge for such storage at least 1% o f he respective invoice balance per each month started, at most 10% of the invoice. 6.4 We select packaging and method of shipment at our discretion. The customer is obligated to check all delivered goods immediately upon receipt and with due care, should visible transport damages be detected, the transport agent must be notified immediately on-site and we are to be informed in writing at least within 5 working days about such damages as well. If the customer should not meet this obligation, delivered goods shall be deemed as having no transport damages.

7. Payment (Price and Payment Terms)

7.1 All prices offered are binding. All given prices shall be understood as “ex-works” excluding packaging and transport without VAT. The customer pays for all taxes, customs duties and any other fees that are due in connection with the sale of our goods, with the exception of the taxes and duties that are our responsibility to pay. 7.2 Our invoices are to be paid within 14 days without deduction. After this period, the customer shall be in default of payment without receiving any additional payment reminders. The customer is not allowed to make unauthorized deductions from our invoices. For payments that we receive prior to the payment deadline, we guarantee a 2% discount, in case it is mentioned on the invoice. 7.3 Banking payment transactions shall only be considered as executed when the complete payment is fully at our disposal by a bank that we have access to. Payment of invoice(s) by check is only possible with our prior authorization. We do not accept bank drafts. 7.4 Debit authorization procedures to the customer’s bank account done in our favor are considered as executed after 5 bank working days. 7.5 Legal delay regulations will also be applicable with regard to interest for default. We also reserve the right to assert further damages by default of payment. 7.6 The off-set of customer’s claims against our demands are excluded, unless these demands are undisputed and regarded as legally effective or are recognized by us. The customer has no right of retention of payments with respect to disputed counterclaims. The transfer of all customers’ claims out of the agreement is excluded.

8. Return of Goods

8.1 The customer has the option to return delivered goods within 30 days from the date of invoice. Our written authorization must be obtained before each return. In such cases, delivery of goods must be free of charge to our domicile Mühlheim a. d. Donau. Implants as well as sterile products having an opened package or a damaged label will not be accepted and will be returned to the customer without a credit note. We will not take back specially made items. 8.2 Returned goods will be credited on the basis of the net product value minus 15%. Should any costs incur for re-work in order to prepare the returned goods for additional sale, these costs will be deducted as well. 8.3 This return option may not be utilized for goods which are not listed in our relevant current price list anymore, for phased-out products or for specially manufactured items. Implants can only be taken back in their original packaging and if they are not opened.

9. Warranty

9.1 We guarantee that our goods are at the most modern standard in medical technology according to the Medical Product Laws (MPG) and flawless in manufacture and material and that the production of the goods is according to the technical standards valid in Germany. 9.2 In case of defects covered by warranty, we will eliminate such defects according to the customer’s decision or deliver new goods. We are authorized to refuse the request to eliminate the defect or delivery of new goods when this is only possible with disproportionate costs and another type of elimination of the defect without considerable disadvantages for the customer remains. 9.3 Should elimination of the defect(s) of the goods delivered not occur within a reasonable period of time, the customer does have statutory rights. By slight defects, the customer does not have the right of withdrawal. When the customer claims damages, we are only liable according to the following liability in Paragraph 10. 9.4 Obvious defective goods are to be brought to our attention in writing within two weeks after receipt of the goods, otherwise such claims become invalid. We must be notified in writing of hidden defects within a time period of one week after they are discovered. A timely dispatch is enough for the adherence to the time limit. 9.5 Claims shall lapse one year after delivery for defective goods that we have delivered, providing there are no special valid legal regulations for medical products. Parts subject to wear, transportation damages as well as damages caused by incorrect treatment or due to the use of unsuitable means of production or chemical, electronic or other influence shall be excluded from the above mentioned warranty.

10. Liability

10.1 We are liable for any damage resulting from damages to the person, body or health only if they are a result of deliberate actions or serious negligence on our part or negligence of one of our legal representatives or subcontractors. Furthermore, we are liable for damage resulting from deliberate actions or serious negligence on our part or negligence of one of our legal representatives or subcontractors. The same applies by violations of substantial contractual obligations or the legal regulations of liability. 10.2 In case of a slight negligent breach of duty, our liability as well as that of our delegated agents shall be limited to the foreseeable, contract-specific and direct average damage. In case of a slight negligent breach of duty of non-substantial contract-specific obligations, neither we nor our delegated agents or sub-contractors accept any liability. Essential contract duties are such duties which make enforcement of the contract feasible and with respect to which the customer may rely us to keep to. We accept no liability for mere negligent breach of contract-specific secondary obligations.10.3 If claims are made by the patient against us as the manufacturer, we are obligated according to the stipulations of German Law on Product Liability that are valid in relationship to our customer, the subcontractor, but who is not the victim, deviates from Paragraph 5, Clause 2 of the German Law on product Liability: To the extent that the manufacturer is also the enterpriser, we are only then liable, subject to the further requirements according to the German Law on Product Liability, as (sub) manufacturer of the products with regard to the cause of the damage when it can be proven that it was due to gross negligence on the part of the customer. The customer has a responsibility towards us, otherwise to be exempt, upon first demand. The liability limitations shall not apply in case we are liable for any bodily harm and injury to health or loss of life. Other claims arising from product liability law or based on special regulations for medical products are not affected by the above provisions. 10.4 We are only liable for our own content on our website. As far as we make access to other websites possible with so-called “links”, we are not responsible for the foreign contents stated there. We do not accept their contents. Where the existence of illegal contents becomes known to us, we shall immediately block access to such websites. 10.5 Any liability being more extensive shall be excluded, particularly for loss of profit. We are, in particular, not liable when our instructions regarding further preparation, respectively, use of the goods is strictly not observed by the customer.

11. Data Privacy

11.1 We wish to point out that according to Paragraph 33, Clause 1 of the Federal Data Protection Act we save and process the customer’s data within the framework of this agreement. 11.2 We are entitled to disclose customer information solely for the purposes of checking credit status and creditworthiness, and to forward on this information, when necessary, to information services. By data processing and transmission, we guarantee the protection of the customer’s data concerns according to the legal regulations and in all cases.

12. Industrial Property Rights

12.1 The customer may use our trademarks, market names and other markings as well as other industrial property rights within the framework and with regard to and being in compliance with the respective commercial protective legislation. 12.2 Should the goods be manufactured based on drawings or other information from the customer, the customer is then solely responsible that there is no violation of any Third Partie’ rights. The customer shall hold us harmless from all claims potentially arising from any Third Parties because of violation of industrial property rights (including all legal costs) and should we request, the customer shall support us to be best of his abilities should we be involved in such action in court.

13. Product Traceability

13.1 The customer will immediately and comprehensively inform us in writing about all incidents and experiences which might constitute a notifyable incident or “almost incident” according to the valid Medical Guidelines (Directive 93/42/EWG and 2007/47/EU as well as Medical Product Laws). The customer shall support us as well as all parties involved to the best of his abilities to clear the facts in such case. 13.2 The customer is to establish product traceability and adhere to such, at least for medical products having a classification IIa, IIb and III (according to Annex IX of the EC-Directive 93/42/EWG and 2007/47/EU). This system enables one to relate each delivered good to the relevant customer being the final user of the good. Therefore, the customer shall pass on to his customer the corresponding LOT number found on each product or product label we deliver. The customer shall inform us immediately and at any time about the way, scope and durance of a trace back when we ask to do so.

14. Contract Language, Applicable Law and Place of Jurisdiction

14.1 The contract language is German. Possible translations serve only as a reading aid. By disputes, respectively by interpretations, only the German version of the contract is valid. 14.2 Only German substantial Law of the Federal Republic of Germany to the exclusion of the United Nation’s Agreement on the International Trade of Goods from April 11, 1980 (CISG – Vienna Convention) is valid. 14.3 The place of performance for all obligations from this contract is Mühlheim/Donau (Germany). Court of jurisdiction for both parties is the court of jurisdiction where the supplier is located. Additionally, we are entitled to take the customer to court at his domicile or at the location of his branch company.

15. Final Provisions

Should a condition of a customer agreement including these General Terms and Conditions of Payment and Delivery be or become unenforceable or unable to be conducted or after conclusion of the agreement become invalid or unable to be conducted , the enforceability of the other conditions remains unaffected. At the points of invalidity or where the point is unable to be conducted, the effective and feasible regulation, whose effectiveness is closest to the economic goals or that is closest to the invalid regulations, takes over. The above regulation also applies in the case of a void.